Kornimate/medical-research-clean huggingface dataset:
celiac plexus radiosurgery for pain management

Conditions: Digestive System Neoplasms

Summary: this prospective study evaluates celiac plexus radiosurgery for pain control in patients with upper abdominal malignancies.

this study aims as primary objective to evaluate short and long term pain relief following the administration of radiosurgery to the celiac plexus in patients with upper abdominal cancer. as secondary objectives it will describe acute and late side effects and quality of life measures of patients undergoing the treatment. the study has a prospective, single arm design. it will be composed from an initial run-in safety assessment that will include 6 patients and then continue as a phase ii trial. all eligible patients will receive the same protocol of celiac plexus radiosurgery and will be evaluated before, during and following this treatment. the treatment duration is one and a half weeks (5 fractions delivered every other weekday).

Eligibility criteria:
inclusion criteria: * patients with upper abdominal cancer (pancreatic/gastric/colon/hepato-biliary cancer) with typical retroperitoneal pain syndrome (somatic pain that radiates from the upper abdomen to the back) thought to be secondary to celiac plexus involvement, directly or indirectly, and have high level of pain despite opioids usage (nrs \>4). patients with other cancer types metastatic to the celiac lymph nodes will also be eligible * recent abdominal imaging (ct, pet or mri) should be at most 2 months old. * prior chemotherapy or biological treatment is allowed, but any active oncological treatment should be stopped at least 1 week prior to radiation and renewed at least 1 week following radiation. following gemcitabine 2 weeks are required between final dose and commencement of radiation * absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial exclusion criteria: * patients under 18 years of age * patients who are well balanced in terms of pain control * patients with life expectancy \<8 weeks * patients with ecog (eastern cooperative oncology group) performance status 4 * any concurrent chemotherapy or biologic treatment is prohibited during 1 week before until 1 week following radiotherapy * special populations: pregnant women, prisoners, patients with major psychiatric illnesses * previous radiotherapy to upper abdomen * conditions associated with increased side effects to radiotherapy (ibd (inflammatory bowel disease) for example)

Keywords: radiosurgery celiac plexus pain quality of life
apixaban for the treatment of venous thromboembolism in patients with cancer

Conditions: Venous Thromboembolism

Summary: apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (probe) study


Eligibility criteria:
inclusion criteria: * consecutive patients with a newly diagnosed, objectively confirmed: symptomatic or unsuspected, proximal lower-limb dvt or symptomatic pe or unsuspected pe in a segmental or more proximal pulmonary artery; * any type of cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or intracerebral metastasis and acute leukemia); * signed and dated informed consent of the patient, available before the start of any specific trial procedure. exclusion criteria: * age \<18 years; * ecog performance status iii or iv; * life expectancy of less than 6 months; related to anticoagulant treatment: * administration of therapeutic doses of lmwh, fondaparinux, or unfractionated heparin (ufh) for more than 72 hours before randomization; * 3 or more doses of a vitamin k antagonist before randomization; * thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index episode; * indication for anticoagulant treatment for a disease other than the index vte episode; related to bleeding risk: * thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy; * active bleeding or a high risk of bleeding contraindicating anticoagulant treatment; * recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery * hemoglobin level lower than 8 g/dl (5.0 mmol/l) or platelet count \<75x10\^9/l or history of heparin induced thrombocytopenia; * creatinine clearance \< 30 ml /min based on the cockcroft gault equation; * acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range; * uncontrolled hypertension (systolic bp\> 180 mmhg or diastolic bp \> 100 mmhg despite antihypertensive treatment); * concomitant use of strong inhibitors or inducers of both cytochrome p-450 3a4 and p-glycoprotein; standard criteria: * bacterial endocarditis; * hypersensitivity to the active substance or to any of the excipients of study drug; * patients participation in other pharmaco therapeutic program with an experimental therapy that is known to effect the coagulation system; * childbearing potential without proper contraceptive measures, pregnancy, or breast feeding; * any condition that as judged by the investigator would place the subject at increased risk of harm if he/she participated in the study.
chronic fatigue etiology and recovery in covid-19 patients: the role of fatigability

Conditions: Chronic Fatigue Syndrome; Intensive Care Unit; Muscle

Summary: chronic fatigue is the most common and debilitating symptom in intensive care unit (icu) survivors. indeed, it has been widely reported that patients who stayed in icu for prolonged periods report a feeling of tiredness for months to years after icu discharge. this symptom seems particularly pronounced in covid-19 patients and may affect their quality of life by decreasing their capacity to perform simple tasks of daily life. the aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in the feeling of fatigue of covid-19 patients. because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. a better knowledge of chronic fatigue etiology and its recovery will allow to optimize rehabilitation treatments to shorten the persistence of chronic fatigue and in fine improve life quality.


Eligibility criteria:
inclusion criteria for patients who have been in intensive care : * diagnosed with covid-19 * ventilated in icu for at least 3 consecutive days * icu discharge between 4 and 8 weeks * approval received from a physician * command of the french language inclusion criteria for patients who have not been in intensive care : * diagnosed with covid-19 : positive serological test or positive pcr test following nasopharyngeal swabbing * approval received from a physician * command of the french language exclusion criteria: * taking neuroactive substances that can alter corticospinal excitability * patients with co-morbidities leading to significant fatigue: e.g. cancerous pathologies, sleep apnea * patients with neurodegenerative or neuromuscular disease * contraindication to the application of a magnetic field * contraindication to the practice of magnetic resonance imaging * participant is pregnant * patients with psychiatric disorders * paraplegic and hemiplegic patients * addictive disorders

Keywords: neuromuscular function fatigability
study of endobarrier liner for treatment of type 2 diabetes study

Conditions: Type 2 Diabetes

Summary: the main objective of the study is to demonstrate the safety and efficacy of the gastrointestinal (gi) endobarrier in the glycemic control of diabetes in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * subjects age \> 18 years and ≤ 55 years * male or female * subjects with type 2 diabetes who have been treated for ≤10 years and are on oral diabetic medications * subjects with an hba1c \> 7.5 and ≤ 10.0% * subjects with a bmi \> 26 - \< 50 * subjects willing to comply with study requirements * subjects who have signed an informed consent form * women who are post-menopausal, surgically sterile or on oral contraceptives and agree to remain on oral contraceptives for at least twenty-four (24) weeks after being implanted or the duration of their trial participation and agree not to become pregnant during the trial. exclusion criteria: * subjects diagnosed with type 1 diabetes mellitus or having a history of ketoacidosis * subjects requiring insulin * subjects with probable insulin production failure (fasting c peptide serum \<1ng/ml) * subjects that have autoimmune disease as evidenced by a positive anti-gad blood test * subjects with a weight loss of \> 4.5 kg (10 lbs) within the 12 weeks of screening * subjects requiring prescription anticoagulation therapy * subjects with or a history of iron deficiency and/or iron deficiency anemia * subjects with or a history of abnormalities of the gi tract * subjects with symptomatic gallstones or kidney stones at the time of screening * subjects with a known infection * subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia * subjects mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement or clinical trial participation * subjects with previous gi surgery that could affect the ability to place the device or the function of the implant * subjects unable to discontinue nsaids (non-steroidal anti-inflammatory drugs) during the implant period * subjects with active h. pylori (note: subjects may be enrolled if they had a prior history of h. pylori and were successfully treated) * subjects receiving weight loss medications such as meridia, xenical, or over the counter weight loss medications * subject or family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder * subjects with active and uncontrolled gerd * subjects with a known history of substance abuse * subjects participating in another ongoing investigational clinical trial * subjects taking corticosteroids or drugs known to affect gi motility (i.e. reglan)

Keywords: diabetes weight loss gi dynamics endobarrier
prospective study on prognosis of cardiac resynchronized therapy (crt), implantable cardioverter defibrillator (icd) implantation in patients with congestive heart failure (chf)

Conditions: Congestive Heart Failure

Summary: crt and icd has known as decreasing cardiac mortality in patient with heart failure. especially, it has reported that crt improved cardiac systolic function, quality of life of patients with heart failure. however, crt and primary icd was not generalized in korea. so the investigators will register patients who implant crt or icd (primary), and follow them up. during scheduled follow up, all patients will perform echocardiography, 6 minute walking test, ekg, holter monitoring and questionnaire on qol.


Eligibility criteria:
inclusion criteria: 1. age \>=18 2. lv ejection fraction \ 40%) 3. medication for at least 3month exclusion criteria: 1. patient who refuse to enroll the study

Keywords: crt, heart failure, icd
study of safety of rvl-1201 in treatment of blepharoptosis

Conditions: Blepharoptosis

Summary: phase 3 study to evaluate the extended safety of rvl-1201 compared to placebo for treatment of blepharoptosis. eligible subjects will be randomized to one of 2 treatment arms.


Eligibility criteria:
inclusion criteria: 1. male or female 9 years of age or older 2. females must not be pregnant or planning to get pregnant and must use acceptable form of contraception 3. must be able to self-administer study medication 4. must be able to understand and sign an informed consent form (icf). for minor subjects, the subject's parent or legal guardian must provide permission by signing an icf on behalf of the subject and the subject should provide assent. exclusion criteria: 1. congenital ptosis 2. horner syndrome 3. myasthenia gravis 4. mechanical ptosis 5. previous ptosis surgery 6. resting heart rate outside the normal range 7. hypertension with resting diastolic blood pressure 8. pregnancy or lactation
efficacy and safety of cilostazol for the indication of csps

Conditions: Cerebral Infarction

Summary: this is a multicenter, open-label, prospective study of cilostazol use for prevention of recurrence in patients with cerebral infarction.

this is a multicenter, open-label, prospective study of cilostazol use to prevention of recurrence in patients with cerebral infarction. qualified patients will be treated with cilostazol by physician's assessment. this study will be continued for 4 years. more than 600 patients for 4 years.

Eligibility criteria:
inclusion criteria: * patient with an experience of cerebral infarction and having a purpose for prevention of recurrence of cerebral infarction. * age: more than 18 years of age exclusion criteria: * unqualified patients judged by study investigator(s)

Keywords: cerebral infarction prevention cilostazol
european paediatric non-alcoholic fatty liver disease registry (eu-pnafld)

Conditions: Non-Alcoholic Fatty Liver Disease; Non-alcoholic Fatty Liver; Non-alcoholic Steatohepatitis

Summary: the eu-pnafld (the european paediatric nalfd registry) will be a network composed of european centres involved in the care of children with nafld, and will include hepatologists, endocrinologists, and scientists, supported by relevant international specialists. this collaboration will build on existing infrastructure (local databases and bio-repositories) and will align with the adult european nafld registry ("epos", elucidating pathways of steatohepatitis study) to allow long-term follow-up supported by translational studies. through an international, well-characterised large-scale cohort, we hope to: facilitate multi-centre clinical trials; extend our understanding of the key disease mechanisms of nafld; and establish the natural history of paediatric nafld.


Eligibility criteria:
inclusion criteria: * diagnosis made under 18 years of age. * diagnosis of nafld spectrum disease (simple steatosis (nafl), steatosis with abnormal transaminases, nash ± fibrosis or cirrhosis) * diagnosis established by: * radiological evidence of hepatic steatosis (e.g. increased hepatic echogenicity on ultrasound), with * exclusion of secondary causes (negative serological liver screen for hbv/hcv, caeruloplasmin \>0.20g/l, no history of excess alcohol consumption, no evidence of iron overload, and no clinically significant alpha-1 antitrypsin (a1at) phenotype (i.e. sz, zz, ss), with or without * histology (\>5% steatosis and histology consistent with paediatric nafld) exclusion criteria: * secondary fatty liver disease (e.g. glycogen storage diseases, wilson disease, viral hepatitis, drug-related, autoimmune hepatitis, type 1 diabetes mellitus) * post-transplant fatty liver * \>20g/day ethanol intake

Keywords: cirrhosis liver disease hepatocellular carcinoma type 2 diabetes atherosclerosis
study of su011248 administered on a continuous daily dosing schedule in patients with gastrointestinal stromal tumor

Conditions: Gastrointestinal Stromal Tumors

Summary: to evaluate the antitumor activity of su011248 in advanced, imatinib mesylate-resistant gastrointestinal stromal tumor (gist) when administered on a continuous daily dosing schedule

subjects experiencing clinical benefit after 1 year on study were offered continued treatment with su011248 on a separate protocol.

Eligibility criteria:
inclusion criteria: * histopathologically proven diagnosis of malignant gist that was not amenable to standard therapy. * failed prior treatment with imatinib mesylate, defined either by progression of disease (according to response evaluation criterion in solid tumors (recist) or world health organization (who) criteria), or by significant toxicity during treatment with imatinib mesylate that precluded further treatment. intolerance to prior imatinib mesylate therapy was defined as follows: * life-threatening adverse events (ie, grade 4) at any dose (attempt to dose reduce or rechallenge not required) or unacceptable toxicity induced by a moderate dose (eg, 400 mg/day), specifically, grade 2 toxicity that was unacceptable to the patient (such as nausea) that persisted despite standard countermeasures * evidence of unidimensionally measurable disease. exclusion criteria: * previous treatment on a su011248 clinical trial. * diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma, that had been adequately treated with no evidence of recurrent disease for 12 months. * history of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. * any of the following within the 12 months prior to starting the study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism. * ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade, or qtc interval \>450 msec for males or \>470 msec for females. * hypertension that could not be controlled by medications (\>150/100 mm/hg despite optimal medical therapy).
macro and microcirculatory effects of the combination of norepinephrine and octreotide for the treatment of cirrhotic patients with hemorrhagic shock

Conditions: Haemorrhagic Shock; Variceal Hemorrhage

Summary: octreotide is used to decrease portal pressure of cirrhotic patients admitted for variceal bleeding. when patients are in haemorrhagic shock, the recommended drug to increase arterial pressure is norepinephrine. microcirculatory effects of octreotide when it is added to noradrenaline has not been investigated yet. the aim of the study is to evaluate the effect of octreotide plus norepinephrine for patient with haemorrhagic shock after variceal bleeding.


Eligibility criteria:
inclusion criteria: * patients more than 18 years old * patient with liver cirrhosis * patient with haemorrhagic shock due to variceal bleeding * patient with an arterial blood pressure less than 65 mmhg despite * patient able to express consent * signed written informed consent form * patient covered by national health insurance exclusion criteria: * patient less than 18 years old * patient non covered by national health insurance * pregnant or breast feeding patent * known octreotide allergy * cardiac arrest because of shock * refused consent

Keywords: microcirculation octreotide norepinephrine variceal hemorrhage haemorrhagic shock
effect of lik066 on glucose absorption in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of the study was to assess the effect of lik066 on intestinal glucose absorption immediately after a single dose (immediate effect) and 6 hours following the dose (after multiple daily doses; sustained effect) in patients with type 2 diabetes mellitus (t2dm).


Eligibility criteria:
inclusion criteria: * patients, age 18-65 years, must have been diagnosed with t2dm at least 6 months prior to screening with hba1c 6.5 to 10.0%, inclusive, at screening. * fasting plasma glucose ≤250mg/dl at screening. * if treated with metformin, patients must be on a stable dose for 12 weeks prior to randomization and maintain the dose until the end of the study. exclusion criteria: * patients with type 1 diabetes mellitus. * patients with history of acute diabetic complications within the 6 months prior to screening. * pregnant or nursing (lactating) women. * women of child-bearing potential unless they are using effective methods of contraception during dosing of study treatment. * patients with signs or symptoms of significant diabetic complications. * patients treated with certain blood pressure or lipid lowering medications unless patients have been on stable doses for the 12 weeks prior to dosing. * history of drug or alcohol abuse within the 12 months prior to dosing. * any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study. other protocol-defined inclusion/exclusion criteria may apply
impaact p1106: pharmacokinetic characteristics of antiretrovirals and tuberculosis medicines in low birth weight infants

Conditions: Low-Birth-Weight Infant; Tuberculosis; HIV

Summary: p1106 is phase iv prospective pharmacokinetic (pk) study of low birth weight infants who are receiving or will be receiving as part of clinical care nevirapine (nvp) prophylaxis, tuberculosis (tb) prophylaxis or treatment and/or combination antiretroviral (arv) treatment containing lopinavir/ritonavir (lpv/r). the study is designed to describe the pharmacokinetics and safety of nvp, inh, rif, and lpv/r in these infants receiving the drug(s) as part of clinical care.


Eligibility criteria:
inclusion criteria: inclusion criteria for arms 1 and 3 (hiv-exposed infants): * breastfeeding infants born to hiv-infected mothers who are receiving either no arv therapy or arv therapy that does not include nvp * age 7 to 14 days * birth weight less than 2500 grams * receiving or will be receiving prophylaxis as prescribed by clinical care provider as follows: nvp (arm 1), nvp plus inh (arm 2), nvp plus inh plus rif (arm 3) * parent or legal guardian able and willing to provide written informed consent. \[note to sites: modify per locally relevant language\]. inclusion criteria for arm 2 (hiv-exposed infants): * breastfeeding infants born to hiv-infected mothers who are receiving either no arv therapy or arv therapy that does not include nvp * age 7 to 84 days * birth weight less than or equal to 4000 grams * receiving or will be receiving prophylaxis as prescribed by clinical care provider as follows: nvp (arm 1), nvp plus inh (arm 2), nvp plus inh plus rif (arm 3) * parent or legal guardian able and willing to provide written informed consent. \[note to sites: modify per locally relevant language\]. inclusion criteria for arm 4 (hiv-unexposed but tb exposed infants): * age 7 to 84 days * birth weight less than or equal to 4000 grams * receiving prophylaxis with inh alone or inh plus rif as prescribed by clinical care provider * not receiving any therapy for hiv prophylaxis or treatment * parent or legal guardian able and willing to provide written informed consent. \[note to sites: modify per locally relevant language\]. inclusion criteria for arms 5 and 6 (hiv-infected infants): * documentation of hiv-1 infection defined as positive hiv dna pcr done as part of clinical care. an hiv rna confirmatory test must be done at study entry but results may be pending at time of enrollment. * birth weight less than or equal to 4000 grams * age less than or equal to 12 weeks (defined as 84 days) * intention by clinical care provider to prescribe lpv/r plus 2 nrtis and no rif (arm 5) or lpv/r plus 2 nrtis plus rif (arm 6) * parent or legally acceptable representative able and willing to provide written informed consent. \[note to sites: modify per locally relevant language\]. exclusion criteria: any severe congenital malformation or other medical condition incompatible with life or that would interfere with study participation or interpretation, as judged by the examining clinician.